Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
radiofrequency heat lesion procedures for the relief of pain

Device Description

The OWL radiofrequency generator URF-3AP is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor, or the destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain.

The URF-3AP supplies up to 50 Watts of Radio Frequency energy at 481kHz in bipolar or monopolar modes under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance.

When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

AI/ML Overview

The provided document describes a 510(k) submission for the DIROS TECHNOLOGY INC. OWL™ RF LESION GENERATOR MODEL OWL URF-3AP. This is a medical device, and the document focuses on demonstrating its substantial equivalence to predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for completely novel devices or AI/software algorithms.

Therefore, much of the requested information regarding acceptance criteria, specific performance statistics, sample sizes, expert involvement, and ground truth for a study is not applicable in the context of this 510(k) submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, lesion size accuracy) are not explicitly stated in this 510(k) summary as they would be for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and compliance with safety and electrical standards.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance:
- Same Indications for Use as Predicate Devices	"All systems provide treatments by making heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain."
- Similar Key Design Technical Characteristics	"Pain relief is achieved by the controlled heating of the area surrounding the electrode tip. A thermosensor in the probe is used to control tissue temperature. Impedance values are displayed to guard against unsafe conditions."
- Same/Similar Components for Treatment and Measurement	Stated as a rationale for substantial equivalence.
- Similar Size, Power Source, and Performance	Stated as a rationale for substantial equivalence.
- Capability to supply up to 50 Watts at 481kHz (bipolar/monopolar)	"The URF-3AP supplies up to 50 Watts of Radio Frequency energy at 481kHz in bipolar or monopolar modes under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance."
- Capability to deliver low-frequency stimulus pulses	"When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes."
Safety and Electrical Performance:
- Compliance with applicable safety, electrical, mechanical, EMC standards	"The DIROS OWL URF-3AP has been subjected to performance testing to applicable safety, electrical, mechanical, EMC standards. The DIROS OWL URF-3AP system has been evaluated and has passed all mechanical and electrical safety according to CSA International. Standards that were investigated are: IEC 60601-1, UL 60601-1 and CAN/CSA C22.2-No.601.1-M90 certified. The URF-3AP has also been evaluated and satisfies the requirements to IEC 601-2-2 Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment."
- Risk Analysis and Mitigation	"A risk analysis identifying potential hazards and documenting mitigations of the hazards has been developed and applied as part of the DIROS OWL URF-3AP product development cycle. The risk analysis is based on EN 1441/ISO14971 - Risk Analysis for Medical Devices."
- Software Performance Validation	"specific performance testing of the software was performed to show that the performance was met."

2. Sample size used for the test set and the data provenance:

Not applicable for a clinical study in this 510(k) context. The "testing" mentioned is primarily engineering and bench testing to demonstrate compliance with standards and functional specifications, not a clinical trial with patient "test sets." The document does not specify a sample size for any clinical test set or data provenance in terms of country of origin or retrospective/prospective nature, as such a study was not the basis for this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical "test set" with ground truth established by experts is described for this type of device submission. Performance is assessed against engineering specifications and compliance with standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an RF lesion generator, not an AI or imaging diagnostic device. No human reader performance, AI assistance, or MRMC study is relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in a clinical sense. The "ground truth" for this engineering-focused submission would be objective technical standards (e.g., a power meter measuring output wattage, a thermometer measuring temperature control accuracy, electrical safety testing results, and functional tests against design specifications).

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, this question is not relevant.

In summary:

This 510(k) submission for the OWL URF-3AP RF Lesion Generator is a regulatory filing focused on demonstrating substantial equivalence to existing legally marketed predicate devices and compliance with relevant performance, safety, and electrical standards. It is not a clinical study involving the detailed metrics (sensitivity, specificity, clinical outcome data, etc.) that would typically be described for diagnostic devices or AI algorithms. The "study" mentioned is primarily bench testing, engineering validation, and regulatory compliance checks against established standards and the specifications of predicate devices.

Summary

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DIROS TECHNOLOGY INC. 510(K) SUBMITTAL OWL™ RF LESION GENERATOR MODEL OWL URF-3AP

K0i2758

510(k) Summary

Submitter:

Page 1 of 3

DIROS TECHNOLOGY INC 232 Hood Road Markham, ON L3R3K8, Canada

Contact:

Mr. George Darmos Telephone: 905-415-3440 Fax: 905-415-0667 gpdarmos@dirostech.com

Date: July 27, 2006

Trade Name: OWL URF-3AP

Common Name: OWL Radiofrequency System

Classification Name: Generator, Lesion, Radiofrequency

Regulatory Class: II

Product Code: GXD

Regulation Number: 882.4400

REGISTRATION NO: 8043398

OWNER/OPERATOR NO: 9001301

SEP 27 2006

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K 062758

DIROS TECHNOLOGY INC. 510(K) SUBMITTAL OWL™ RF LESION GENERATOR MODEL OWL URF-3AP

Predicate Devices:

Page 2 of 3

We are making the claim that the DIROS OWL URF-3AP is substantially equivalent to the predicated devices listed in the chart below.

LEGALLYMARKETEDPREDICATE DEVICE	MANUFACTURENAME	REGULATORYCLASS ANDPRODUCTCODE	510(K)REGISTRATIONNUMBER
OWL URF-2AP	DIROSTECHNOLOGYINC	Class II/GXD	K021869
PMG-115	BAYLISMEDICALCOMPANY	Class II/GXD	K020354

The rationale of declaring the DIROS OWL URF-3AP is substantially equivalent to the above 2 predicate devices is based on the following:

Same Indications for use: All systems provide treatments by making heat ablative > lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. All systems are using the same fundamental scientific technology.
Similar key design technical characteristics- Pain relief is achieved by the controlled heating of the area surrounding the electrode tip. A thermosensor in the probe is used to control tissue temperature. Impedance values are displayed to guard against unsafe conditions.
Same/similar components for treatment and measurement. >
Similar size, power source, and performance

Description:

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GY INC. 510(K) SUBMITTAL RF LESION GENERATOR MODEL OWL URF-3AP

destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain.

When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

Indications for Use:

The DIROS® URF-3AP LESION GENERATOR is intended for the following:

1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
1. radiofrequency heat lesion procedures for the relief of pain

Summary of Performance Testing:

A risk analysis identifying potential hazards and documenting mitigations of the hazards has been developed and applied as part of the DIROS OWL URF-3AP product development cycle. The risk analysis is based on EN 1441/ISO14971 - Risk Analysis for Medical Devices.

Testing was performed to validate the functional performance of the DIROS system. In particular, specific performance testing of the software was performed to show that the performance was met.

The DIROS OWL URF-3AP has been subjected to performance testing to applicable safety, electrical, mechanical, EMC standards. The DIROS OWL URF-3AP system has been evaluated and has passed all mechanical and electrical safety according to CSA International. Standards that were investigated are: IEC 60601-1, UL 60601-1 and CAN/CSA C22.2No.601.1-M90 certified. The URF-3AP has also been evaluated and satisfies the requirements to IEC 601-2-2 Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment.

Conclusion:

As stated above, DIROS TECHNOLOGY INC.'s conclusion is that the DIROS OWL URF-3AP is safe and effective and complies with the appropriate medical standards and is substantially equivalent to the above identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diros Technology, Inc., % Mr. George Darmos President 232 Hood Road Markham, Ontario Canada L3R 3K8

SEP 2 7 2006

Re: K062758

Trade/Device Name: OWL Radiofrequency System, Model URF-3AP Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD, GXI Dated: August 3, 2006 Received: September 15, 2006

Dear Mr. Darmos:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. George Darmos

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Fur Panta

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K062758 510(k) Number (if known):

OWL Radiofrequency System, Model URF-3AP Device Name:

Indications For Use:

The OWL Radiofrequency System, Model URF-3AP, intended use is for:

1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
1. radiofrequency heat lesion procedures for the relief of pain

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Devige Evaluation (ODE)

Veshm

(Division Sign-On) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 882.4400 Radiofrequency lesion generator.

(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).